Platelet Reactivity After Cessation of Clopid in the Setting of Coronary Stent Implantation I: PRACTICE I

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00684359

Acronym

PRACTICE I

Enrollment

Registered

2008-05-26

Start date

2007-06-30

Completion date

2010-02-28

Last updated

2010-05-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronary Disease

Keywords

Patients having PCI with a drug eluting stent

Brief summary

Single center randomized parallel group study to determine if: 1. there is a temporary increase in platelet reactivity after abrupt discontinuation of clopidogrel due to a potential rebound phenomenon. 2. the effect of sudden discontinuation of clopidogrel 6 months post coronary angioplasty with adjunct drug eluting stent implantation compared to 12 month continuation of clopidogrel on platelet reactivity. And the association with MACE up to 12 months post coronary angioplasty.

Interventions

None listed

Study design

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Patients, male or female, \> 18 years of age, * Patients who are scheduled for an elective PCI with a drug eluting stent * Patients willing to return for all required follow up visits. * Patients live/work within a 60 mile radius of the Washington Hospital Center.

Exclusion criteria

* Patient has experienced an acute myocardial infarction within the preceding 48 hours of the subsequent angioplasty. * Unprotected left main coronary disease with \>50% stenosis; * Patients with renal failure requiring dialysis; * Patients with a documented ejection fraction \< 30 percent at the time of subsequent PCI; * Patient with a life expectancy less than 12 months or malignancy. * Known allergies to aspirin or clopidogrel bisulfate (PlavixR) and that cannot be medically managed; * Planned surgery or other indication for requiring the cessation of clopidogrel within 12 months of PCI; * Any significant medical condition which in the investigator's opinion may interfere with the patient's optimal participation in the study. * Patients with known history of bleeding diathesis; * Prothrombin time \>1.5 times control; coumadin therapy * Platelet count \<100 000/mm3; * Hematocrit \<25%; * Creatinine \>4.0 mg/dL; * Thienopyridine use within 5 days of enrollment * Glycoprotein (GP) IIb/IIIa use within 8 hours of enrollment or any indication were the operator will require GP IIb/IIIa inhibitor use during the hospitalization.

Design outcomes

Primary

Measure	Time frame
To determine if there is a temporary increase in platelet reactivity after abrupt discontinuation of clopidogrel due to a potential rebound phenomenon	Up to 12 months

Secondary

Measure	Time frame
To determine what the effect of sudden discontinuation of clopidogrel 6 months post coronary angioplasty with adjunct drug eluting stent implantation compared to 12 month continuation of clopidogrel on platelet reactivity.	up to 12 months

Countries

United States

Outcome results